FDA 483 - The Methodist Hospital Research Institute - February 13, 2026

The Methodist Hospital Research Institute, a PET drug manufacturer in Houston, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate oversight of production operations leading to data integrity concerns with electronic instrumentation and a failure to review original electronic data. The firm also failed to follow written quality assurance procedures regarding environmental monitoring excursions and lacked adequate production and process controls for sanitization. Additionally, issues with equipment cleaning and maintenance were noted, potentially affecting product sterility.